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A Study of NeoRecormon in Patients With Chronic Kidney Disease.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00437723
First received: February 19, 2007
Last updated: May 13, 2009
Last verified: May 2009
  Purpose

This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 g/L), or to a control group not receiving NeoRecormon. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Anemia
Drug: epoetin beta [NeoRecormon]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Investigate the Effect of NeoRecormon on Hemoglobin Level and Renal Function in Patients With Chronic Kidney Disease, Stage 2-4

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Hb level, decline in renal function, 24h proteinuria, creatinine clearance. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SAEs, AEs leading to withdrawal, AEs related to NeoRecormon. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 90
Study Completion Date: April 2008
Arms Assigned Interventions
Experimental: 1 Drug: epoetin beta [NeoRecormon]
At a dose to achieve and maintain an Hb level of 120-135g/dL.
No Intervention: 2

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients,18-75 years of age;
  • end-stage renal disease, not on dialysis;
  • Hb <110g/L.

Exclusion Criteria:

  • unstable hypertension;
  • acute infections;
  • use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon;
  • myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437723

Locations
Serbia
Belgrade, Serbia, 11000
Novi Sad, Serbia, 21000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00437723     History of Changes
Other Study ID Numbers: ML20200
Study First Received: February 19, 2007
Last Updated: May 13, 2009
Health Authority: Serbia: Ministry of Health

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014